On June 29, 2023 K36 Therapeutics ("K36"), a privately held clinical-stage biotech company developing KTX-1001, an investigational small molecule methyltransferase inhibitor of multiple myeloma SET (MMSET) domain, reported a $70M Series B financing (Press release, K36 Therapeutics, JUN 29, 2023, View Source [SID1234632989]). The round was led by Nextech Invest, Ltd, a precision medicine focused investment firm, on behalf of one or more funds managed by it, with participation from Bristol Myers Squibb Company (NYSE:BMY), and other undisclosed investors. All existing investors including Atlas Venture, F-Prime Capital, and Eight Roads Ventures participated in the round.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The funds will support the ongoing Phase 1 study of KTX-1001, planned clinical studies of KTX-1001 in combination with existing standard-of-care agents in multiple myeloma, and the expansion of KTX-1001 into additional hematological and solid tumor indications. KTX-1001 is a novel, first-in-class, potent, and selective catalytic inhibitor of the H3K36 methyltransferase MMSET. It is an orally administered small molecule being developed initially for treating relapsed and refractory multiple myeloma, focusing on patients with the genetic translocation t(4;14).

"We are committed to developing KTX-1001 for t(4;14) multiple myeloma patients, a large patient population with chronic disease who are relatively unresponsive to existing and emerging therapeutics," said Terry Connolly, Ph.D., Chief Executive Officer of K36 Therapeutics. "We welcome our new investors who bring extensive expertise in cancer drug development as well as company building, and we are proud of the continued commitment from of our existing investors. This financing comes at a key time for K36 as we look forward to establishing KTX-1001 clinical proof of concept in multiple dosing regimens and demonstrating the expanded opportunity for KTX-1001 in additional hematologic and solid tumor malignancies."

K36 also announced that in conjunction with the Series B financing, Melissa McCracken, Ph.D., Partner at Nextech, will be joining K36’s Board of Directors.

"Nextech invests in emerging biotechnology companies that are developing transformative cancer medicines," said Dr. McCracken, "The K36 team has made remarkable progress since the company’s formation, advancing the only known selective inhibitor of MMSET into clinical development. I am excited to be a part of the K36 Board of Directors, and look forward to the continued clinical progress with KTX-1001 for the treatment of t(4;14) multiple myeloma, and beyond."

About KTX-1001
KTX-1001 is an investigational product and is the only clinical-stage inhibitor of MMSET, an oncogenic driver of multiple myeloma in patients with genetic translocation t(4;14). A phase 1 clinical trial in adult subjects with relapsed and refractory multiple myeloma is on-going. The Phase 1 clinical trial is a single-arm, open-label, multi-part study with dose escalation followed by an expansion cohort in patients with the genetic translocation t(4;14) to evaluate the safety, tolerability, and preliminary efficacy of different doses of KTX-1001.

On June 29, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that it will be presenting clinical data on its lead asset TAC01-HER2 for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer taking place in Barcelona, Spain, June 28 – July 1, 2023 (Press release, Triumvira Immunologics, JUN 29, 2023, View Source [SID1234632988]). The upcoming presentation will feature the latest clinical findings obtained from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) among patients with relapsed or refractory solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are honored to share our latest advancements in precision cell therapy at ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer. Our innovative and well differentiated TAC01-HER2 cell therapy holds great promise in the treatment of HER2 positive solid tumors." said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "This phase 1 data presentation represents a significant step forward in our mission to transform cancer care through the natural potential of T cells. We look forward to contributing to the scientific dialogue and working towards a future where targeted T cell therapeutics redefine the landscape of cell therapies in solid tumors, specifically in late stage gastric and esophageal cancers which has been an area of significant unmet need for a long time."

"These positive results are encouraging for the potential safety and efficacy of TAC01-HER2 in patients with relapsed or refractory solid tumors," said Dr. Ecaterina Dumbrava, assistant professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and investigator of the study. "These outcomes also warrant further investigation on the potential of TAC01-HER2 in this significant area of unmet clinical need."

ESMO World Congress on Gastrointestinal Cancer Presentation Details:

Title: A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors
Authors: Ecaterina Dumbrava
Category: Clinical Gastric Cancer
Subcategory: Metastatic Disease
Date and Time: June 29, 9:30 am – 17:40 pm
Abstract Number: P-31

Abstracts are currently available on the World Congress of Gastrointestinal Cancer website under the abstracts section. All abstracts will be published to the Annals of Oncology website on Saturday, July 1, 2023, at 16:30 p.m. CEST.

On June 29, 2023 Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, and Quantum Leap Healthcare Collaborative ("Quantum Leap") reported that six patients have been dosed with Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, in the ongoing Phase 2 I-SPY 2 clinical trial. (Z)-endoxifen is being evaluated as a neoadjuvant treatment for patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit (Press release, Atossa Therapeutics, JUN 29, 2023, View Source [SID1234632987]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The I-SPY 2 TRIAL is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. The (Z)-endoxifen treatment arm, which is expected to enroll approximately 20 patients, is part of the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP). Patients will receive 10 mg of (Z)-endoxifen daily for up to 24 weeks prior to surgery. Currently, there are 41 I-SPY 2 sites, all of which have the EOP program open.

"Reaching 30% enrollment in the I-SPY 2 study is another important milestone in our ambitious (Z)-endoxifen development program," said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. "These patients have substantial risk for recurrence and need novel treatments options that are more tolerable and more efficacious than currently approved drugs. (Z)-endoxifen has the potential to slow the progression of ER-positive breast cancer in the neoadjuvant setting, making surgery more effective and reducing the risk of recurrence. We look forward to seeing data from this trial, which along with data from our Phase 2 EVANGELINE trial, will inform conversations with the FDA and our planned Phase 3 protocol."

"With the ISPY 2.2 TRIAL, we have focused on optimizing treatments for the fast-growing breast cancers; that focus has allowed us to make great progress. But one of the biggest challenges in breast cancer is the hormone positive breast cancers that are slow growing. They can recur for up to 15 years or more, and we urgently need to find predictors of response so that we can prevent late recurrence. And we know that women suffer from the side effects of years of extended endocrine therapy, especially when they have larger tumors. So, we have a great need to find more effective and more tolerable agents so that women with live longer and better. The goal of the endocrine optimization pilot is to test these new and exciting hormone directed therapies like endoxifen," said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY TRIAL.

About Premenopausal Patients with ER+ / HER2- Breast Cancer
Breast cancer is the most frequently diagnosed cancer in premenopausal women worldwide and accounts for almost half of the cancers that occur in women aged 15-49. An overwhelming majority (75%) of premenopausal breast cancer falls under luminal A (ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian function suppression, when combined with either tamoxifen or an aromatase inhibitor, is the standard of care for the endocrine management of stage 2 and 3 premenopausal ER+/HER2- breast cancer. The I SPY Endocrine Optimization Pilot (EOP) specifically targets women of all ages with molecularly low risk stage 2 and 3 breast cancer.

About (Z)-Endoxifen
(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the therapeutic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein.

Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions in the stomach convert a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. The Company is currently studying (Z)-endoxifen in three Phase 2 studies: one in healthy women with measurable breast density and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by three issued U.S. patents and numerous pending patent applications.

On June 29, 2023 Devyser reported the launch of two new products, Devyser LynchFAP and Devyser BRCA PALB2 (Press release, Devyser Diagnostics, JUN 29, 2023, View Source [SID1234632986]). These kits offer efficient, targeted, and confident analysis of genes associated with increased cancer risk, such as those involved in Lynch syndrome, and in breast and ovarian cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

New comprehensive solution for Lynch syndrome testing

Devyser LynchFAP provides a comprehensive solution to analyze PMS2 and 9 other genes associated with hereditary colorectal cancer syndromes. Devyser LynchFAP is designed to overcome one of the greatest challenges for Lynch syndrome genetic testing – the localization of genetic variants to PMS2 and its pseudogene PMS2CL. Devyser LynchFAP is the first commercial library prep kit to allow this specific analysis of the PMS2 gene.

With a simple next-generation sequencing (NGS) workflow, this test and dedicated software enable our users to disentangle complex genetics with an intuitive and easy-to-use solution. Devyser is proud to add Devyser LynchFAP to its expanding oncology offering.

The importance of hereditary cancer testing

Colorectal cancer is the third most common cancer worldwide. 10-20% of cases are due to hereditary cancer syndromes such as Lynch syndrome. Having a hereditary cancer syndrome significantly increases an individual’s risk of developing colorectal cancer, among multiple other cancer types. It is estimated that 1 in 300 individuals carry mutations in DNA mismatch repair genes, such as those associated with Lynch syndrome. The challenge is that many people, up to 95% in certain regions, do not know that they carry these mutations.

Targeting the information that matters most

Devyser BRCA PALB2 provides a targeted solution with the simplest commercially available workflow for crucial genetic information related to breast and ovarian cancer. This kit allows for the sequencing of genetic variants in BRCA1, BRCA2, and PALB2, the three most significant genes increasing breast cancer risk. The simplified workflow of Devyser BRCA PALB2 enables fast laboratory implementation and streamlines two applications in one solution – the analysis of genetic variants in DNA from human blood and tumor tissue.

"We are delighted to introduce Devyser LynchFAP and Devyser BRCA PALB2 to the market," says Fredrik Alpsten, CEO of Devyser. "These genetic testing solutions represent a significant advancement in our hereditary cancer offering. By understanding mutations associated with increased cancer risks, our ambition is to enable more personalized care and preventive measures, ultimately saving lives."

Devyser is committed to advancing genetic testing technologies to improve patient outcomes and contribute to the field of personalized medicine. With the launch of Devyser LynchFAP and Devyser BRCA PALB2, the company is taking a significant step towards achieving its mission of enabling early detection and targeted interventions for individuals at risk of hereditary cancer syndromes.

For more information about Devyser’s innovative genetic testing solutions, please visit www.devyser.com or contact [email protected].

On June 29, 2023 Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, reported clinical results of its novel KRAS G12C inhibitor glecirasib monotherapy and in combination therapy with cetuximab to treat KRAS G12C mutant advanced CRC (colorectal cancer) in Second JCA- AACR (Free AACR Whitepaper) Precision Medicine International Conference (Press release, Jacobio Pharmaceuticals, JUN 29, 2023, View Source [SID1234632985]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the monotherapy study, overall response rate (ORR) is 33.3% (11/33), disease control rate (DCR) is 90.9% (30/33), mPFS (median progression-free survival) is 6.9 months.

In a trial of glecirasib with cetuximab, ORR is 62.8% (27/43), DCR is 93% (40/43). mPFS has not reached before the data cutoff date on May 23, 2023.

The majority TRAEs (treatment related adverse event) are grades 1-2.

Colorectal cancer is the second most common cancer in China, with about 550,000 new cases per year, of which about 3% of colorectal cancer patients have KRAS G12C mutation. Patients with KRAS G12C mutation are insensitive to existing standard chemotherapies and targeted therapies, have rapid disease progression, short survival, and they have high unmet clinical treatment needs. Glecirasib has potential to bring effective and less toxic treatment option for patients.

About Glecirasib

Glecirasib is Jacobio’s novel KRAS G12C inhibitor. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors harbouring KRAS G12C mutation, including a pivotal clinical trial int NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting; combination therapy trials with SHP2 inhibitor JAB-3312, anti-PD-1 antibody and Cetuximab.